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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name System, Image Processing, Radiological
510(k) Number K010259
Device Name MEDIFACE PACS
Applicant
Mediface Co., Ltd.
2001 E. Oak Shores Dr.
Aubrey,  TX  76227
Applicant Contact CARL PERSON
Correspondent
Mediface Co., Ltd.
2001 E. Oak Shores Dr.
Aubrey,  TX  76227
Correspondent Contact CARL PERSON
Regulation Number892.2050
Classification Product Code
LLZ  
Date Received01/29/2001
Decision Date 04/26/2001
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Radiology
510k Review Panel Radiology
Type Traditional
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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